Cross design analysis of randomized and observational data - application to continuation rates for a contraceptive intra uterine device containing Levonorgestrel in adolescents and adults

被引：6

作者：

Vaitsiakhovich, Tatsiana ^{[1
]}

Filonenko, Anna ^{[2
]}

Lynen, Richard ^{[3
]}

Endrikat, Jan ^{[4
,5
]}

Gerlinger, Christoph ^{[5
,6
]}

机构：

[1] Bayer AG, RWE Strategy & Outcomes Data Generat, Mullerstr 178, D-13353 Berlin, Germany

[2] Bayer AG, Market Access Pulmonol & Womens Healthcare, Mullerstr 178, D-13353 Berlin, Germany

[3] Bayer US LLC, US Med Affairs Womens Healthcare, 100 Bayer Blvd, Whippany, NJ 07981 USA

[4] Bayer AG, Radiol, Mullerstr 178, D-13353 Berlin, Germany

[5] Univ Saarland, Med Sch, Gynecol Obstet & Reprod Med, D-66421 Homburg, Saar, Germany

[6] Bayer AG, Stat & Data Insights, Mullerstr 178, D-13353 Berlin, Germany

来源：

BMC WOMENS HEALTH | 2018年 / 18卷

关键词：

Cross design syntheses; Continuation rates; Intra-uterine device;

D O I：

10.1186/s12905-018-0674-1

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

BackgroundTo combine results from a randomized controlled study (RCT) and an observational study (OS) to evaluate discontinuation rate of a levonorgestrel-containing intrauterine contraceptive device (LNG IUD) in a real-life setting.MethodsWe included 253 parous and nulliparous women aged 21-40years from our own phase II RCT. A total of 1607 women of all ages (including adolescents, <20years) were recruited from an OS. We applied the cross design synthesis (CDS) method recommended by the United States General Accounting Office. This method combines the different strengths of RCTs and OSs into one single estimate.ResultsCombined continuation rates for parous vs nulliparous women could be estimated more precisely as well as overall continuation rates after one (86.6%) and two years (78.5%), irrespective of age and parity.ConclusionCross design synthesis allowed more precise estimation of continuation rates of an intrauterine device.

引用

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